Sonrotoclax Plus Dexamethasone With or Without Daratumumab Regimen in Patients With t(11;14) Prim… (NCT07335887) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Sonrotoclax Plus Dexamethasone With or Without Daratumumab Regimen in Patients With t(11;14) Primary AL Amyloidosis
39 participantsStarted 2026-01-01
Plain-language summary
The goal of this study is to evaluate the efficacy and safety of Sonrotoclax combined Regimen in patients with t(11;14) AL amyloidosis. Participants will receive the Sonrotoclax Plus Dexamethasone regimen with or without Daratumumab for 12 cycles. The Hematologic Response, Organ Response, Survival, and Safety will be evaluated.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients who meet the diagnostic criteria for Primary Systemic Light Chain Amyloidosis (according to the Systemic Light Chain Amyloidosis Diagnosis and Treatment Guidelines (2021 Revision)).
✓. Age ≥ 18 years.
✓. Confirmed FISH test result of t(11;14) positive by each center or a third-party laboratory, or a prior FISH test report indicating t(11;14) positivity
✓. ECOG Performance Status score of 0-2.
✓. Presence of measurable disease, defined by at least one of the following criteria:
✓. Serum M-protein ≥ 0.5 g/dL
✓. Serum free light chain (FLC) level ≥ 40 mg/L with an abnormal kappa/lambda ratio.
✓. Adequate organ function, defined as:
Exclusion criteria
✕. Meets the diagnostic criteria for active multiple myeloma or active lymphoplasmacytic lymphoma
✕. Presence of other malignancies at an advanced stage with systemic metastases.
✕. IgM-type AL amyloidosis.
✕. Prior treatment with a BCL-2 inhibitor (BCL-2i).
✕. Presence of any of the following severe cardiovascular diseases
What they're measuring
1
Best hematological ≥VGPR rate within four cycles of therapy
Timeframe: At the end of Cycle 4 (each cycle is 28 days)